STRIDES PHARMA FDA Approval ANDA 090055

ANDA 090055

STRIDES PHARMA

FDA Drug Application

Application #090055

Documents

Other2015-07-06

Application Sponsors

ANDA 090055STRIDES PHARMA

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL250MG0MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL

FDA Submissions

ORIG1AP2010-06-10
REMS; REMSSUPPL2AP2012-09-25
LABELING; LabelingSUPPL3AP2012-08-29STANDARD
LABELING; LabelingSUPPL4AP2013-09-27STANDARD
REMS; REMSSUPPL5AP2015-11-13
LABELING; LabelingSUPPL6AP2016-08-01STANDARD
LABELING; LabelingSUPPL14AP2019-11-22STANDARD
LABELING; LabelingSUPPL16AP2020-08-04STANDARD
REMS; REMSSUPPL17AP2021-01-15
REMS; REMSSUPPL20AP2021-04-21
REMS; REMSSUPPL21AP2021-08-11

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL3Null15
SUPPL4Null7
SUPPL5Null7
SUPPL6Null15
SUPPL14Null15
SUPPL16Null15
SUPPL17Null15
SUPPL20Null7
SUPPL21Null7

TE Codes

001PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90055
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOPHENOLATE MOFETIL","submission":"MYCOPHENOLATE MOFETIL","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.